- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07371442
Effect of AV Distraction and Acuapoint Stimulation in Pediatric Extraction on Pain and Anxiety (AV Acupoint)
Effectiveness of Audiovisual Distraction and Acuapoint Stimulation on Anxiety and Pain Perception During Tooth Extraction in Children: A Randomized Controlled Clinical Study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Al Mansurah, Egypt
- Faculty of Dentistry Mansoura University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1- Children with behavior rating score 2,3 according to Frankl's behavior rating scale.
2- Children aged 5-8 years requiring primary tooth extraction. 3- Healthy children free of systemic diseases
Exclusion Criteria:
- 1- Children with special health care needs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: dental story
A dental video story will be presented to patient using an iPad device connected to a noise cancellation headphone.
|
A dental video story will be presented to the patient using an iPad device connected to a noise cancellation headphone.
|
|
Experimental: Aculief
Aculief acupressure device will be placed on the LI4 Point which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart.
The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger.
The duration will be 5 minutes before LA administration.
to patients
|
Aculief acupressure device will be placed on the LI4 Point (figure 1) which is located on the hand between the thumb and index finger, also described as the depression where the index finger and thumb bone go apart. The LI4 point will be identified in each patient by asking the patient to adduct the thumb and index finger. The duration will be 5 minutes before LA administration. The administration of local anesthesia in all groups will be achieved by 1.8 ml of 2% Lidocaine with 1/100,000 epinephrine using a 30-gauge long needle |
|
Experimental: TSD
This group will be treated using Tell-show-do technique
|
This group will be treated using Tell-show-do technique
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).
|
Anxiety will be measured by A) Pulse oximeter: Pulse oximeter was used to observe the physiological functions like heart rate and SpO₂. B) Venham's picture test: the child was presented with eight different cards. Each card held two pictures-a representation of the child expressing anxiety along with another representation of the same child in a relaxed mood. The child was asked to point out the picture in each pair that resembled how he/she was feeling. There was also an order in which the pictures had to be presented. Assigning the image depicting anxiety the score of 1 and the relaxed image the score of 0 helped in the coding process. |
Will be measured 5 minutes before LA , immediately before extraction and immediately after extraction The total VPT score was obtained by summing the values across all eight panels, with higher scores indicating greater levels of anxiety (range: 0-8).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain of the patient
Time Frame: Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)
|
will be evaluated by Wong baker FACES pain scale which is consist of six faces numbered ordinary from 0 to 5. ranging from a no pain (score 0) to one showing severe pain (score 5)
|
Will be evaluated immediately after the local anesthesia and tooth extraction using Wong Baker FACES Pain rating scale, ranging from a no pain (score 0) to one showing severe pain (score 5)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A03012024PP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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